Tensive is a biomedical company developing an innovative scaffold aiming to improve breast cancer patients’ quality of life, by offering a natural breast reconstruction.
We are looking for an Equipment Specialist (ES) to work closely with our Production, QA&RA and R&D teams. The ES will collaborate in the management of the company’s equipment, coordinating installation, corrective, and preventive maintenance activities of the same using internal resources and / or external collaborations. The ES will report directly to the Chief Operating Officer (COO) and will collaborate with both internal and external teams.
We love to hire collaborative and self-motivated people with a passion for learning and a teamwork spirit. Our team invests heavily in coaching new hires.
The ES will directly be involved in the following activities, as assigned by the COO:
- Ensure the continuous efficiency, functionality and safety of production and research & development plants, machines and equipment, in compliance with internal procedures and interfacing with external companies where necessary and authorized;
- Identify the right mix of maintenance policies in order to guarantee production continuity and the desired levels of plant / instrumental availability;
- Manage the ordinary and extraordinary maintenance of the company’s plants, equipment and instruments, in compliance with the Quality Management System (QMS);
- Creation and monitor of KPIs related to maintenance;
- Guarantee prompt intervention in the event of breakdowns or anomalies in the production process and R&D plants and machinery, with the aim of minimizing machine downtime;
- Propose initiatives aimed at optimizing plant and machinery, supporting company functions in identifying and implementing improvement actions;
- Verify and ensure the continuous efficiency of the security devices and alarm systems with the aim of avoiding accidents, injuries and damage to workers, machines and the facility;
- Participate in the preparation of the company for the inspections of the Authorities and contribute to the success of the same, collaborating subsequently in the implementation of any corrective actions, if necessary;
- Identify actions to ensure continuous updating and suitability for the role in relation to the new knowledge required;
- Prepare and update the SOP and written operating instructions regarding the maintenance of the company’s premises, systems and equipment;
- Execute and manage, with the supervision of the responsible Chief and in collaboration with the competent company functions, the validation activities related to machinery, utilities, instruments. Supervise the qualification and validation of new plants, machinery and equipment, specifically checking in in particular, the correct execution of the required functionality and calibration tests, the pre-start-up and start-up tests;
- Manage and keep up-to-date the machinery and equipment register and specific documentation (instrument sheets, maintenance reports, instruction manuals, documents and technical drawings, operating procedures, installation reports, operational and performance qualifications, etc.) taking care of the recording of all data relating to the maintenance activities and interventions carried out, as well as the description of any changes and ordinary and extraordinary maintenance interventions;
- Manage the traceability process of calibration and maintenance of the measurement tools;
- Monitor the stocks of spare parts and consumables, ensuring that they are constantly adapted to real needs;
- Collaborate with the Warehouse Assistant (WA) in warehouse management.
- Organize the movements and transfers of materials to and from the company in accordance with company procedures and with the appropriate carrier.
- Support the company in managing software.
The successful candidate will be part of the Procurement team, will work closely with the the members of the Production, R&D, and QA&RA teams, report directly to the COO and collaborate with the WA to ensure that all of the above-mentioned activities are completed according to Tensive’s implementation timeline.
- Industrial or technical expert diploma in the electrical and mechanical industries;
- Previous experience in a medical or pharmaceutical company;
- Ability to read and understand a technical manual in Italian and English;
- Excellent knowledge of the Microsoft Office package;
- Proficiency in written and spoken English is required.
- Excellent interpersonal skills with the ability to interact and communicate effectively;
- Ability to independently organize his/her own schedule to achieve goals and meet projects and company deadlines;
- Excellent attitude to teamwork and ability to work in a small, fast-growing startup environment;
- Ability to manage stress during intense working periods;
- Problem solving and critical thinking skills.
- Experience in medical device companies is preferred.